Understanding Medical Device Software Standards: Ensuring Safety and Efficacy in Healthcare
In the realm of healthcare, medical devices play a pivotal role in diagnosing, monitoring, and treating various medical conditions and…
Software Architecture according to IEC 62304
In this article we will go through the requirements associated to Software Architecture according to IEC 62304:2006/AMD-1:2015. The IEC 62304…
Software as Medical Device (SaMD) : What Do you Need to Know?
SAMD – Software As Medical Device became more and more spread within the healthcare. The worldwide spread of software applications…
IEC 62304:2006 – Medical Device Software
IEC 62304:2006 is an internationally recognised medical device standard which provides a framework for the development, testing and maintenance of…
Artificial Intelligence and Machine Learning as Medical Device Software
Artificial Intelligence for Medical Device: new challenges for regulatory compliance.